SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII) - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00455923

Purpose

An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.

Condition	Intervention	Phase
Asthma	Drug: Seretide Drug: Flixotide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Advair

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of patients in each arm with a need of an increase of study medication

Secondary Outcome Measures:

Bronchial hyperresponsiveness, number of symptom free days and nights, number of exacerbations, time to first exacerbation, time to increase of study medication
1. Bronchial hyper-responsiveness both change from baseline and change in values at the end of the study.
2. Number of symptom-free days and nights without use of rescue medication.
3. Number of exacerbations. 4. Time to first exacerbation. 5. Time to increase of study medication

Estimated Enrollment:	100
Study Start Date:	May 2005
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Willing to give informed consent.
Males or females aged 18-70.
Able to understand and complete dairy cards.
Mild persistent asthma according to GINA. In addition, at randomisation subjects were required to have: 1. Day time symptoms more than once a week but not every day. 2. Night-time symptoms not more than once a week. 3. FEV1 >80% predicted 4. PC20 <8mg/mL

Exclusion Criteria:

Change to regular asthma medication in 4-weeks prior to visit 1.
Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
Lower respiratory tract within 4 weeks of Visit 1
Received investigational study drug within 4 weeks of visit
Smoking history of >10 pack years of more.
Serious uncontrolled disease.
Medical conditions or medications known to affect the assessments or endpoints.
Evidence of alcohol or drug abuse.
Known pregnancy or planned pregnancy.
Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
Previous enrollment in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455923

Locations

Sweden
GSK Investigational Site
LULEÅ, Sweden, SE-971 89

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM103976, SAM103976
Study First Received:	April 3, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00455923 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:

mild
persistent
asthma

GINAII
exacerbation
bronchial hyperresponsiveness

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 25, 2009